Job Description

· To plan, coordinate, and execute the establishment and commissioning of pharmaceutical manufacturing facility, ensuring compliance with GMP, ISO, and regulatory requirements, while meeting project timelines and budgets.

· Project Planning & Coordination

· Develop master project schedules and work breakdown structures (WBS).

· Coordinate with architectural, HVAC, clean room, utility, and process equipment vendors.

· Execution & Monitoring

· Supervise construction, equipment installation, qualification, and validation.

· Ensure compliance with URS, cGMP, ISO 13485, and regulatory body expectations

· Stakeholder Management

· Interface with consultants, contractors, internal teams, and government authorities.

· Quality & Safety Assurance

· Ensure adherence to EHS standards and validation protocols.

· Cost & Risk Management

· Track project expenses, control cost overruns, an manage project risks.

 

Key Deliverables / KPIs:

· On-time project completion

· Budget adherenc

· GMP-compliant plant handover

· Successful qualification and validation (DQ, IQ, OQ, PQ)

· Minimal regulatory observations